Overview

This trial is active, not recruiting.

Condition peripheral arterial disease
Treatment zilver® ptx® drug-eluting peripheral stent
Sponsor Cook
Start date August 2013
End date January 2017
Trial size 200 participants
Trial identifier NCT01901289, 12-004

Summary

The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
zilver® ptx® drug-eluting peripheral stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Primary Outcomes

Measure
Occurrence of target lesion revascularization (TLR).
time frame: 1 year

Secondary Outcomes

Measure
Target lesion revascularization (TLR)
time frame: annually through five years post-procedure.
Stent Integrity
time frame: one, three, and five years post-procedure.
Stent thrombosis
time frame: annually through five years post-procedure.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has signed and dated the informed consent. - Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. - Patient agrees to return for the required follow-up assessments. Exclusion Criteria: - Patient is < 18 years of age. - Patient has significant stenosis of inflow tract not successfully treated before this procedure. - Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.

Additional Information

Official title Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Cook.